MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Loss of consciousness (2418)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3777-60 lot# serial# (b)(4) implanted: 2012 (b)(6)explanted: product type lead product id 3777-60 lot# serial# (b)(4) implanted: 2012(b)(6)explanted: product type lead product id 37712 lot# serial# (b)(4) implanted: 2011(b)(6)explanted: product type implantable neurostimulator product id 3777-60 lot# serial# (b)(4) implanted: 2012 (b)(6) explanted: product type lead product id 3777-60 lot# serial# (b)(4) implanted: 2012 (b)(6) explanted: product type lead product id 37712 lot# serial# (b)(4) implanted: 2011 (b)(6) explanted: product type implantable neurostimulator product id 3777-45 lot# serial# (b)(4) implanted: 2011 (b)(6) explanted: product type lead product id 3777-45 lot# serial# (b)(4) implanted: 2011 (b)(6) explanted: product type lead.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information from patient via the manufacturers representative reported that the patient was not able to feel the stimulation from the implantable neurostimulators (ins).The patient had one spinal cord stimulator (scs) system and one peripheral nerve stimulator (pns) system.The patient fell 2 months ago and reported a loss of consciousness (loc) and went to the emergency room (er).The patient did have x-rays taken but they were not available to the manufacturer.They then had a second fall 2 weeks following the previously mentioned fall and had more pain in the lower back.An impedance check performed showed values within normal limits for the scs system and values all above 10 ,000 ohms on the pns system.More x-rays were to be taken on (b)(6) 2016.The issue was not resolved at the time of report.The patient status was not as alive  no injury.The indications for use for the implanted device were noted as cervical radiculopathy, radiculopathy, and spinal pain.

Event Description

Additional information received from the consumer via the manufacturer¿s representative (rep) reported they had a lack of therapy from one of their leads, but there were no factors reported that could have led or contributed to this.An impedance check was performed prior to surgery with all impedances out of range (oor).The other lead was providing stimulation in the stomach, but there were no factors reported that could have led or contributed to this either.An impedance check was performed and an x-ray was taken with impedances within range, but the lead looked like it was too far lateral.As a result the lead that was providing a lack of therapy with high impedances was replaced resulting in the impedance results being in range, and the lead that was too far lateral and providing stimulation in the stomach was revised to be more midline resolving the issues.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6103386
• MDR Text Key: 59923720
• Report Number: 3004209178-2016-24044
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2017
• Date Device Manufactured: 08/02/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR